In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Suprane Drug Master File in Korea (Suprane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Suprane. The MFDS reviews the Suprane KDMF as part of the drug registration process and uses the information provided in the Suprane KDMF to evaluate the safety and efficacy of the drug.
After submitting a Suprane KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Suprane API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Suprane suppliers with KDMF on PharmaCompass.